Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against AlloVir, Inc. due to allegations of violations of federal securities laws related to misleading statements about the posoleucel Phase 3 studies [1][2]. Summary by Sections Legal Investigation - Faruqi & Faruqi, LLP is encouraging investors who suffered losses exceeding $25,000 in AlloVir stock or options between March 22, 2022, and December 21, 2023, to contact them for legal options [1]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [2]. Allegations Against AlloVir - The complaint alleges that AlloVir and its executives made false and misleading statements regarding the posoleucel Phase 3 studies, including: - The studies were unlikely to meet their primary endpoints [2]. - The likelihood of discontinuation of the posoleucel Phase 3 studies [2]. - Overstating the efficacy and commercial prospects of posoleucel [2]. - Public statements made by the company were materially false and misleading [2]. Stock Price Impact - Following the announcement on December 22, 2023, that AlloVir would discontinue the posoleucel Phase 3 studies due to efficacy concerns, the stock price fell by $1.57 per share, or 67.38%, closing at $0.76 per share [3]. Class Action Details - The lead plaintiff in a class action is the investor with the largest financial interest who directs the litigation on behalf of the class [3]. - Any member of the class can move the court to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [3].

Group 1 - AlloVir, Inc. (ALVR) has shown a year-to-date return of approximately 4.4%, outperforming the Medical sector average return of about -0.9% [2][3] - The Zacks Consensus Estimate for ALVR's full-year earnings has increased by 57.9% in the past quarter, indicating improved analyst sentiment and a more positive earnings outlook [2] - AlloVir, Inc. currently holds a Zacks Rank of 2 (Buy), suggesting it is positioned to outperform the broader market in the near term [1][2] Group 2 - AlloVir, Inc. is part of the Medical - Drugs industry, which consists of 192 individual stocks and is currently ranked 94 in the Zacks Industry Rank [3] - The Medical - Drugs industry has experienced a year-to-date loss of about -0.9%, indicating that ALVR is performing better than its industry peers [3] - In comparison, Arcutis Biotherapeutics, Inc. (ARQT), another stock in the Medical sector, has achieved a year-to-date return of 64.1% and also holds a Zacks Rank of 2 (Buy) [2][3]

Core Viewpoint - AlloVir, Inc. (ALVR) has experienced a significant decline of 72.4% in its stock price over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Stock Performance and Technical Indicators - The stock has been under heavy selling pressure, leading to an RSI reading of 28.82, indicating it may be oversold and could bounce back towards its previous equilibrium [4]. - The Relative Strength Index (RSI) is a momentum oscillator that helps identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. Group 2: Earnings Estimates and Analyst Consensus - There is a strong consensus among sell-side analysts that ALVR will report better earnings than previously predicted, with a 59.1% increase in the consensus EPS estimate over the last 30 days [4]. - ALVR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a favorable outlook for a potential turnaround [5].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________to __________________ Commission File Number: 001-39409 ALLOVIR, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (S ...

Financial Performance - The company reported net losses of $45.3 million and $86.5 million for the three and six months ended June 30, 2023, respectively, with an accumulated deficit of $552.2 million as of the same date [91]. - The company has not generated any revenue from product sales and relies on equity and debt financing for operations [93]. - The company anticipates continued significant operating losses due to ongoing R&D activities, regulatory approvals, and expansion of manufacturing capabilities [92]. - The company anticipates significant future operating losses as it advances product candidates through clinical development and seeks regulatory approval [123]. - The company reported a net loss of $86.5 million for the six months ended June 30, 2023, partially offset by non-cash charges of $19.5 million [129]. Funding and Capital - The company has raised a total of $292.0 million from its IPO and $126.4 million from a securities purchase agreement in July 2022, with a recent public offering generating net proceeds of $70.2 million [88][90]. - The company has raised approximately $156.3 million from preferred stock sales and $292.0 million from common stock in its IPO, among other financing activities [120]. - The company expects to finance its cash needs through equity offerings, debt financings, and collaborations, which may dilute shareholder ownership [125][126]. - The company may need to delay or limit product development if unable to raise additional funds through equity or debt financings [126]. Research and Development - The lead product, posoleucel, is being studied in three ongoing Phase 3 trials, with data readouts expected in 2024, targeting six viruses [88]. - The company is developing additional investigational VST therapies, including ALVR106 for respiratory diseases and ALVR107 for hepatitis B, with ALVR107 expected to enter a POC study after posoleucel's Phase 3 studies [88]. - Research and development expenses increased to $34.8 million for the three months ended June 30, 2023, compared to $31.4 million for the same period in 2022, reflecting a $3.4 million increase [111]. - For the six months ended June 30, 2023, research and development expenses totaled $65.5 million, up from $60.4 million in the same period in 2022, marking a $5.1 million increase [116]. - The increase in research and development costs was primarily due to a $4.6 million rise in expenses related to the development of posoleucel, driven by clinical trial costs and manufacturing outsourcing [111]. - The company plans to increase research and development expenses significantly in the foreseeable future to support ongoing clinical trials and product development [102]. Cash and Investments - As of June 30, 2023, the company had cash, cash equivalents, and short-term investments of $246.5 million, expected to fund operations for at least twelve months [94]. - Cash, cash equivalents, and short-term investments were $246.5 million as of June 30, 2023, expected to fund operations for at least the next twelve months [122]. - Net cash used in operating activities was $59.2 million for the six months ended June 30, 2023, compared to $75.4 million for the same period in 2022, reflecting a decrease of $16.1 million [129][130]. - Net cash provided by investing activities was $79.6 million for the six months ended June 30, 2023, primarily due to investment maturities of $93.8 million [131]. - Net cash provided by financing activities was $70.5 million for the six months ended June 30, 2023, primarily from $70.2 million in net proceeds from the issuance of common stock [132]. - The company reported a net increase in cash, cash equivalents, and restricted cash of $90.9 million for the six months ended June 30, 2023 [128]. Operational Challenges - The company is assessing the impact of COVID-19 on its operations, which has previously caused delays in clinical trials [94][96]. - The company has entered into a relationship with ElevateBio for drug development and manufacturing services, with shared management roles [97]. - The change in net operating assets and liabilities for the six months ended June 30, 2023, was primarily due to an increase of $4.9 million in accounts payable and accrued expenses [129]. - The company has not experienced material changes to its contractual obligations during the six months ended June 30, 2023 [133]. - The company continues to rely on exemptions and reduced reporting requirements as an emerging growth company under the JOBS Act [135][136].

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for Q1 2023, detailing a **net loss of $41.2 million** and **total assets of $244.0 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | March 31, 2023 (in thousands USD) | December 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $115,698 | $106,092 | | Short-term investments | $86,872 | $127,703 | | Total current assets | $212,275 | $243,052 | | **Total assets** | **$244,044** | **$277,079** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $24,959 | $24,338 | | Total liabilities | $50,512 | $52,560 | | Total stockholders' equity | $193,532 | $224,519 | | **Total liabilities and stockholders' equity** | **$244,044** | **$277,079** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Research and development | $30,718 | $29,067 | | General and administrative | $12,513 | $14,126 | | **Loss from operations** | **$(43,231)** | **$(43,193)** | | Interest income | $1,325 | $148 | | **Net loss** | **$(41,183)** | **$(43,863)** | | **Net loss per share — basic and diluted** | **$(0.44)** | **$(0.69)** | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$224.5 million** at December 31, 2022, to **$193.5 million** at March 31, 2023, primarily driven by the **net loss of $41.2 million**, partially offset by **$10.0 million** in stock-based compensation[33](index=33&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(32,118) | $(46,476) | | Net cash provided by (used in) investing activities | $41,724 | $(54,979) | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $9,606 | $(101,455) | | Cash, cash equivalents, and restricted cash at end of period | $116,550 | $101,058 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - AlloVir is a late clinical-stage cell therapy company, with its lead product, posoleucel, in three ongoing Phase 3 trials expected to report data in 2024, following positive Phase 2 results in February 2023[38](index=38&type=chunk) - The company believes its **$202.6 million** in cash, cash equivalents, and short-term investments as of March 31, 2023, are sufficient to fund planned operations for at least twelve months, addressing going concern considerations[40](index=40&type=chunk)[44](index=44&type=chunk) - The adoption of ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), on January 1, 2023, did not materially impact the condensed consolidated financial statements[52](index=52&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operational results, reporting a **net loss of $41.2 million** for Q1 2023, with **$202.6 million** in cash sufficient for twelve months of operations - The company's lead product, posoleucel, is in three ongoing Phase 3 registrational trials with data readouts expected in 2024, following positive Phase 2 results for BK viremia in kidney transplant patients in February 2023[89](index=89&type=chunk) Comparison of Operating Expenses (in thousands USD) | Expense Category | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | Change (in thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | $30,718 | $29,067 | $1,651 | | General and administrative | $12,513 | $14,126 | $(1,613) | | **Total operating expenses** | **$43,231** | **$43,193** | **$38** | - As of March 31, 2023, the company held **$202.6 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations and capital expenditures for at least the next twelve months[94](index=94&type=chunk)[115](index=115&type=chunk) - Net cash used in operating activities decreased to **$32.1 million** in Q1 2023 from **$46.5 million** in Q1 2022, primarily due to the timing of changes in net operating assets and liabilities[123](index=123&type=chunk)[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures for this item - As a smaller reporting company, AlloVir is not required to disclose quantitative and qualitative information about market risk[134](index=134&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - The company's management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023[136](index=136&type=chunk) - No material changes in the company's internal control over financial reporting occurred during the quarter[137](index=137&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the reporting date, the company is not a party to any material arbitration or legal proceedings[141](index=141&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks, including dependence on posoleucel's success, high development costs, need for additional funding, and intense competition - The company's business is highly dependent on its lead product candidate, posoleucel, and its ability to complete clinical testing and obtain regulatory approval[7](index=7&type=chunk)[179](index=179&type=chunk) - As a late clinical-stage entity, the company has incurred **net losses since inception**, with an **accumulated deficit of $507.0 million** as of March 31, 2023, and anticipates significant future losses[7](index=7&type=chunk)[216](index=216&type=chunk) - Substantial additional funding is required, and an inability to raise capital could force delays, reductions, or elimination of development programs or commercialization efforts[8](index=8&type=chunk)[220](index=220&type=chunk) - The company faces substantial competition from other pharmaceutical and biotechnology companies, which could significantly impact its commercial opportunities if competitors develop more successful products[10](index=10&type=chunk)[163](index=163&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities during the quarter[280](index=280&type=chunk) [Item 3. Defaults Upon Senior Securities](index=66&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - There were no defaults upon senior securities[280](index=280&type=chunk) [Item 4. Mine Safety Disclosures](index=66&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[280](index=280&type=chunk) [Item 5. Other Information](index=66&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period - There is no other information to report[280](index=280&type=chunk) [Item 6. Exhibits](index=67&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including Sarbanes-Oxley certifications and Inline XBRL data files - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[285](index=285&type=chunk) - The report incorporates various Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation) for financial data tagging[281](index=281&type=chunk)[282](index=282&type=chunk)[283](index=283&type=chunk)

Allogeneic, Off-the-Shelf, Virus-Specific T Cell Therapies in Late-Stage Development February 2023 ...

Product Development - The company is developing three innovative allogeneic virus-specific T cell (VST) therapy candidates targeting 11 different viruses, with the lead product posoleucel aimed at significantly improving outcomes for transplant patients [500]. - Posoleucel is currently being studied in three ongoing Phase 3 trials, with expected completion of enrollment by the end of 2023 and potential data readouts in 2024 [501]. - ALVR106 and ALVR107 are additional investigational VST therapies in development, targeting respiratory diseases and hepatitis B, respectively [502]. - The company has faced disruptions in clinical trials and operations due to the ongoing COVID-19 pandemic, impacting timelines and patient enrollment [511]. - The company expects to incur significant expenses and operating losses as it advances product candidates through clinical development and seeks regulatory approval [537]. Financial Performance - The company reported net losses of $168.7 million and $172.0 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $465.8 million as of December 31, 2022 [506]. - The net loss for the year ended December 31, 2022, was $168.7 million, an improvement from a net loss of $171.9 million in 2021 [527]. - Cash, cash equivalents, and short-term investments totaled $233.8 million as of December 31, 2022, expected to fund operations for at least twelve months [509]. - Net cash used in operating activities was $142.1 million for the year ended December 31, 2022, compared to $106.3 million in 2021 [543]. - Net cash provided by financing activities was $127.0 million for the year ended December 31, 2022, primarily from the issuance of common stock [546]. Expenses - The company has incurred significant operating losses primarily due to research and development activities and general administrative costs, with expectations of continued increasing expenses [507]. - Research and development expenses were $118.9 million for the year ended December 31, 2022, a decrease of $1.9 million from $120.7 million in 2021 [530]. - General and administrative expenses increased to $52.3 million in 2022 from $49.1 million in 2021, reflecting a $3.2 million increase [531]. Capital and Financing - The company has not generated any revenue from product sales and relies on capital raising through equity and debt financings to support operations [503]. - The company has received net cash proceeds of approximately $156.3 million from preferred stock sales and $292.0 million from common stock in its IPO [534]. - The relationship with ElevateBio includes shared management and support for drug development and manufacturing services, enhancing the company's operational capabilities [513]. Accounting and Compliance - The company utilizes U.S. GAAP for its consolidated financial statements, requiring estimates and judgments that may affect reported amounts of assets and liabilities [552]. - Stock-based compensation expense is recognized based on the grant date fair value, with a graded-vesting basis for performance conditions [554]. - The fair value of stock options is estimated using the Black-Scholes option-pricing model, considering factors such as expected volatility and risk-free interest rates [556]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay compliance with certain accounting standards [562]. - The company will remain an emerging growth company until it meets specific revenue or market value thresholds, including total annual gross revenues of at least $1.0 billion [566]. - The company is also classified as a "smaller reporting company," with market value held by non-affiliates less than $700 million and annual revenue below $100 million [567]. - Recent accounting pronouncements that may impact financial position and results of operations are disclosed in the consolidated financial statements [568]. - As a smaller reporting company, the company is not required to disclose quantitative and qualitative disclosures about market risk [570].

AlloVir Key Investment Highlights - Posoleucel has franchise potential in stem cell (allo-HCT) and solid organ transplant (SOT) patients[5] - AlloVir has $234 million cash as of December 31, 2022[5] Posoleucel Clinical Trials and Data - Three ongoing global Phase 3 registrational trials for three first-to-market indications are expected to complete enrollment in 2023[5] - Topline Phase 2 data in kidney transplant is expected in Q1 2023[5] - Phase 2 CHARMS Treatment Study Demonstrated 93% Efficacy In Treatment-Refractory Patients[40] - 23 out of 26 (88%) patients CSI-free through Week 14 in Phase 2 Prevention Study[33] - 22 out of 26 (85%) patients reactivated ≥1 target virus in Phase 2 Prevention Study[33] Posoleucel Market Opportunity - Posoleucel has a potential >$1 billion commercial opportunity in Allo-HCT alone[65] - Multi-virus infections are common in allo-HCT patients and contribute to significant mortality, with 61% of patients treated with antiviral therapies within the first 100 days[23] Pipeline and Platform - The VST platform minimizes antigen competition, enabling retention of VST diversity and polyclonality[9] - Rationally designed cell bank, facilitating availability of VSTs covering >95% of patients[9]

Financial Performance - The company reported net losses of $42.1 million and $130.6 million for the three and nine months ended September 30, 2022, respectively, with an accumulated deficit of $427.6 million [99]. - The net loss for the nine months ended September 30, 2022, was $130.6 million, compared to a net loss of $114.0 million for the same period in 2021 [139][140]. - Non-cash charges for the nine months ended September 30, 2022, included stock compensation expense of $32.3 million [139]. - The company has not generated any revenue from product sales and relies on equity and debt financing to support its operations [96][100]. Funding and Financing Activities - The company has raised a total of $418.4 million through various financing activities, including an IPO that generated net proceeds of $292.0 million and a Securities Purchase Agreement that raised $126.4 million [96][98]. - The company has raised approximately $156.3 million from preferred stock sales, $292.0 million from common stock in its IPO, and $126.4 million from a Securities Purchase Agreement [130]. - Net cash provided by financing activities was $126.7 million for the nine months ended September 30, 2022, primarily from net proceeds of $126.4 million from the issuance of common stock [144]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations until substantial product revenues are generated [136]. Research and Development - The company is conducting three Phase 3 pivotal trials and two Phase 2 proof-of-concept trials for its lead product, posoleucel, targeting six viruses, with final data expected by year-end 2022 and early 2023 [96]. - The company has initiated a Phase 1b/2 proof-of-concept clinical study for ALVR106, targeting respiratory diseases, and is advancing ALVR107 for chronic hepatitis B treatment, with preclinical studies expected to be completed in 2022 [96]. - Research and development expenses for Q3 2022 were $30.0 million, a decrease of $3.1 million from $33.1 million in Q3 2021, primarily due to reduced costs in manufacturing outsourcing [121]. - Research and development expenses for the nine months ended September 30, 2022, included $44.2 million for posoleucel, an increase of $13.2 million from $31.0 million in the same period of 2021 [127]. - The company anticipates significant increases in research and development and general administrative costs as it advances product candidates through clinical development and seeks regulatory approval [132]. Operational Challenges - The ongoing COVID-19 pandemic has caused delays in clinical trials and may continue to disrupt operations, impacting the company's ability to advance its product candidates [101][104]. - The company has incurred significant operating losses primarily due to research and development expenses and anticipates continued increases in expenses as it expands clinical trials and product development [99][100]. Cash and Liquidity - As of September 30, 2022, the company had cash, cash equivalents, and short-term investments totaling $264.1 million, expected to fund operations for at least twelve months [101]. - Cash, cash equivalents, and short-term investments as of September 30, 2022, totaled $264.1 million, expected to fund operations for at least the next twelve months [131]. - Net cash used in operating activities was $110.5 million for the nine months ended September 30, 2022, compared to $78.3 million for the same period in 2021, reflecting a $32.2 million increase due to higher research and development expenses [139][140][141]. - Net cash used in investing activities was $94.0 million for the nine months ended September 30, 2022, primarily due to the purchase of investments totaling $191.3 million [142]. Company Classification - The company remains classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards [147]. - The company is also classified as a "smaller reporting company," with market value held by non-affiliates below $700 million and annual revenue below $100 million [150]. Contractual Obligations - There were no material changes to contractual obligations during the nine months ended September 30, 2022, except for modifications to manufacturing suites [145]. - The company has no ongoing material financing commitments expected to affect liquidity over the next five years, aside from manufacturing, licensing, and lease obligations [130].